Abstract

The study by Greenberg et al1 published in this issue of Circulation details the results of the randomized clinical trial known as the Multicenter trial of the Orqis Medical Cancion system for the ENhanced Treatment of heart failure Unresponsive to Medical therapy (MOMENTUM). The Orqis device is a new entry into the field of temporary mechanical circulatory support for severe heart failure. The authors point to the growing number of patients with this condition and the very high in-hospital and short-term mortalities that are typically associated with conventional medical or surgical therapy. Thus, new simple methods of providing temporary circulatory support to allow identification of individuals with reversible dysfunction to improve, while adequately supporting the circulation to prevent multiorgan failure and the high likelihood of death in those without improvement in cardiac function, would be a significant advance in management of this population. Article p 1241 Conducting clinical trials on patients who are this ill with very advanced heart failure is, understandably, very difficult, owing to the presence of multiple comorbidities with adverse events that are, potentially, not a direct result of the therapy being evaluated. The cohort of 168 patients enrolled in the MOMENTUM trial1 were typical of this population, with low blood pressure and cardiac output as well as impaired renal function despite intravenous inotrope and/or vasodilator therapy. The trial randomized patients to optimal medical therapy with or without addition of the continuous aortic flow augmentation device. The primary composite end point was a reduction in pulmonary capillary wedge pressure (PCWP) and days alive out of hospital at 35 days post support. A modest goal of the study was that the device could provide an …

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